IVD-体外诊断医疗器械
IVD - In vitro diagnostic medical devices-Directive 98/79/EC - 体外诊断医疗器械体外诊断，即IVD(In Vitro Diagnosis)，是指在人体之外，通过对人体样本(血液、体液、组织等)进行检测而获取临床诊断信息，进而判断疾病或机体功能的产品和服务。体外诊断产品主要由诊断设备（仪器）和诊断试剂构成。根据我国国家药品监督管理局（NMPA）的《医疗器械分类目录》标准，体外诊断设备属于临床检验分析仪器类。IVD体外诊断医疗器械产品分类体外诊断仪器
[*]按诊断方法分：临床化学分析仪器、免疫化学分析仪器、血液分析仪器、微生物分析仪器。
[*]按搭配试剂分：开放式系统、封闭式系统。
体外诊断试剂
[*]按检验原理分：生化诊断试剂、免疫诊断试剂、分子诊断试剂、微生物诊断试剂、尿液诊断试剂、凝血类诊断试剂、血液学和流式细胞诊断试剂。
主要测试标准
[*]EN 61326-1 / GB 18268-1
[*]测量，控制和实验室用电气设备。电磁兼容性要求。第1部分：一般要求
[*]Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirements
[*]EN 61326-2-6:2006 / GBT 18268.26-2010
[*]测量，控制和实验室用电气设备 - EMC要求 - 第2-6部分：特殊要求 - 体外诊断（IVD）医疗设备
[*]测量控制和实验室用的电设备 电磁兼容性要求 第26部分：特殊要求 体外诊断 IVD 医疗设备
[*]Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IVD - In vitro diagnostic medical devices-Directive 98/79/EC - 体外诊断医疗器械
根据联盟协调立法公布的协调标准参考文献
ESO (1)Reference and title of the standard
(and reference document)First publication OJReference of superseded standardDate of cessation of presumption of conformity of superseded standard
Note 1
CENEN 556-1:2001Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices31/07/2002 EN 556:1994 + A1:1998
Note 2.130/04/2002
EN 556-1:2001/AC:2006
15/11/2006
CENEN 556-2:2015Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices13/05/2016 EN 556-2:2003
Note 2.130/06/2016
CENEN ISO 11137-1:2015 (new)Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)This is the first publication
CENEN ISO 11137-2:2015Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)13/05/2016 EN ISO 11137-2:2013
Note 2.130/06/2016
CENEN ISO 11737-2:2009Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)07/07/2010
CENEN 12322:1999In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media09/10/1999
EN 12322:1999/A1:2001
31/07/2002 Note 330/04/2002
CENEN ISO 13408-1:2015Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)13/05/2016 EN ISO 13408-1:2011
Note 2.130/06/2016
CENEN ISO 13408-2:2011Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)19/08/2011
CENEN ISO 13408-3:2011Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)19/08/2011
CENEN ISO 13408-4:2011Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)19/08/2011
CENEN ISO 13408-5:2011Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)19/08/2011
CENEN ISO 13408-6:2011Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)19/08/2011
CENEN ISO 13408-7:2015Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)13/05/2016
CENEN ISO 13485:2016 (new)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)This is the first publicationEN ISO 13485:2012
Note 2.131/03/2019
EN ISO 13485:2016/AC:2016 (new)
This is the first publication
CENEN 13532:2002General requirements for in vitro diagnostic medical devices for self-testing17/12/2002
CENEN 13612:2002Performance evaluation of in vitro diagnostic medical devices17/12/2002
EN 13612:2002/AC:2002
02/12/2009
CENEN 13641:2002Elimination or reduction of risk of infection related to in vitro diagnostic reagents17/12/2002
CENEN 13975:2003Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects21/11/2003
CENEN 14136:2004Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures15/11/2006
CENEN 14254:2004In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans28/04/2005
CENEN 14820:2004Single-use containers for human venous blood specimen collection28/04/2005
CENEN ISO 14937:2009Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)07/07/2010 EN ISO 14937:2000
Note 2.130/04/2010
CENEN ISO 14971:2012Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)30/08/2012 EN ISO 14971:2009
Note 2.130/08/2012
CENEN ISO 15193:2009In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)07/07/2010
CENEN ISO 15194:2009In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)07/07/2010
CENEN ISO 15197:2015In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)13/05/2016 EN ISO 15197:2013
Note 2.131/07/2016
For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30/06/2017.
CENEN ISO 15223-1:2016 (new)Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15)This is the first publicationEN 980:2008
Note 2.131/12/2017
CENEN ISO 17511:2003In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)28/04/2005
CENEN ISO 18113-1:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)27/04/2012 EN ISO 18113-1:2009
Note 2.130/04/2012
CENEN ISO 18113-2:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)27/04/2012 EN ISO 18113-2:2009
Note 2.130/04/2012
CENEN ISO 18113-3:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)27/04/2012 EN ISO 18113-3:2009
Note 2.130/04/2012
CENEN ISO 18113-4:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)27/04/2012 EN ISO 18113-4:2009
Note 2.130/04/2012
CENEN ISO 18113-5:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)27/04/2012 EN ISO 18113-5:2009
Note 2.130/04/2012
CENEN ISO 18153:2003In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)21/11/2003
CENEN ISO 20776-1:2006Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)09/08/2007
CENEN ISO 23640:2015In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)13/05/2016 EN 13640:2002
Note 2.130/06/2017
CenelecEN 61010-2-101:2002Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61010-2-101:2002 (Modified)17/12/2002
CenelecEN 61326-2-6:2006Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 61326-2-6:200527/11/2008
CenelecEN 62304:2006Medical device software - Software life-cycle processes
IEC 62304:200627/11/2008
EN 62304:2006/AC:2008
18/01/2011
CenelecEN 62366:2008Medical devices - Application of usability engineering to medical devices
IEC 62366:200727/11/2008
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